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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001618-18 | EudraCT Number | ||
| PHRC | Other Grant/Funding Number | French Ministry of Health |
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The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoid (GC) tapering | Active Comparator | "GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA). In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo. |
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| Hydrocortisone replacer | Active Comparator | "Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucoCorticoid | Drug | After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group". After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone. |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients who could withdraw from prednisone and hydrocortisone at one year | To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission. | one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients who could withdraw from prednisone | To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment. | one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement |
| proportion of patients with acute adrenal insufficiency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeline RUYSSEN-WITRAND, MD, PhD | University Hospital of Toulouse, Rheumatology Center | Study Chair |
| Arnaud CONSTANTIN, MD, PhD | University Hospital of Toulouse, Rheumatology Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | France | ||||
| Brest University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39874233 | Result | Ruyssen-Witrand A, Brusq C, Masson M, Bongard V, Salliot C, Poiroux L, Nguyen M, Roux CH, Richez C, Saraux A, Vergne-Salle P, Morel J, Flipo RM, Piperno M, Gottenberg JE, Marotte H, Soubrier M, Gossec L, Dieude P, Lassoued S, Zabraniecki L, Couture G, Boyer JF, Jamard B, Degboe Y, Constantin A. Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial. Ann Rheum Dis. 2025 Jan;84(1):49-59. doi: 10.1136/ard-2024-226620. Epub 2025 Jan 2. |
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To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups. |
| one year |
| proportion of patients with biological adrenal insufficiency | To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups. | one year |
| proportion of patients needing extra prednisone to control flares | To compare the proportion of patients needing extra prednisone to control flares | one year |
| proportion of patients who have at least one flare confirmed by the investigator during the protocol. | To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol. | one year |
| area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis) | To compare the area under the curve of the means of the FLARE (Flare Assessment in Rheumatoid Arthritis) at one year with a self-assessment questionnaire. | one year |
| proportion of patients in DAS28 remission and in DAS28 low disease activity | To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups. | 7 and 12 months |
| medians of Health Assessment Questionnaire (HAQ) | To compare the medians of HAQ at 4, 7 months and one year between the groups. | 4, 7 months and 1 year |
| medians of Rheumatoid Arthritis Impact of Disease (RAID) | To compare the medians of RAID at 4, 7 months and one year between the groups. | 4, 7 months and 1 year |
| medians of EuroQol 5-dimensional Descriptive system (EQ-5D) | To compare the medians of EQ-5D at 4, 7 months and one year between the groups. | 4, 7 months and 1 year |
| medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F) | To compare the medians of FACIT-F at 4, 7 months and one year between the groups. | 4, 7 months and 1 year |
| proportion of patients with Serious Adverse events | To compare the proportion of patients with Serious Adverse events at one year between the groups. | 1 year |
| Brest |
| France |
| Jean Rougier Hospital | Cahors | France |
| Clermont-Ferrand Hospital | Clermont-Ferrand | France |
| Bicêtre Hospital | Le Kremlin-Bicêtre | France |
| Lille Hospital | Lille | France |
| Limoges Hospital | Limoges | France |
| Montpellier Hospital | Montpellier | France |
| Pasteur Hospital | Nice | France |
| Orléans Hospital | Orléans | France |
| Bichat Hospital | Paris | France |
| Cochin Hospital | Paris | France |
| La Pitié-Salpétrière | Paris | France |
| Lyon Sud Hopsital | Pierre-Bénite | France |
| Saint-Etienne Hospital | Saint-Etienne | France |
| Strasbourg Hospital | Strasbourg | France |
| Hospital Pierre-Paul Riquet | Toujouse | 31059 | France |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| D011241 | Prednisone |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D015065 | 17-Hydroxycorticosteroids |
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